Dymista 137 micrograms / 50 micrograms per actuation, Nasal Spray Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Azelastine hydrochloride; FLUTICASONE PROPIONATE; Water, purified

Available from:

IMED Healthcare Ltd.

ATC code:

R01AD; R01AD58

INN (International Name):

Azelastine hydrochloride; FLUTICASONE PROPIONATE; Water, purified

Dosage:

137/50 microgram(s)

Pharmaceutical form:

Nasal spray, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids; fluticasone, combinations

Authorization status:

Authorised

Authorization date:

2017-04-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DYMISTA® 137 MICROGRAMS/50 MICROGRAMS
PER ACTUATION NASAL SPRAY, SUSPENSION
AZELASTINE HYDROCHLORIDE/FLUTICASONE PROPIONATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes
any possible side effects not listed in this leaflet.
• Please tell your doctor if you are taking or have recently taken
any other
medicines, including medicines obtained without a prescription.
• Some medicines may increase the effects of Dymista Nasal Spray and
your
doctor may wish to monitor you carefully if you are taking these
medicines
(including some medicines for HIV: ritonavir, cobicistat).
WHAT IS IN THIS LEAFLET:
1. What Dymista is and what it is used for
2. What you need to know before you use Dymista
3. How to use Dymista
4. Possible side effects
5. How to store Dymista
6. Contents of the pack and other information
1. WHAT DYMISTA NASAL SPRAY IS AND WHAT IT IS USED FOR
Dymista Nasal Spray contains two active substances: azelastine
hydrochloride and fluticasone propionate.
• Azelastine hydrochloride belongs to a group of medicines called
antihistamines. Antihistamines work by preventing the effects of
substances
such as histamine that the body produces as part of an allergic
reaction –
thus reducing symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called
corticosteroids which reduces inflammation.
Dymista Nasal Spray is used to relieve the symptoms of moderate to
severe
seasonal and perennial allergic rhinitis if the use of either
intranasal
antihistamine or corticosteroid alone is not considered sufficient.
Seasonal and perennial allergic rhinitis are allergic reacti

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dymista 137 micrograms / 50 micrograms per actuation, Nasal Spray
Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of suspension contains 1000 micrograms azelastine hydrochloride
and 365 micrograms fluticasone propionate.
One actuation (0.14g) delivers 137 micrograms azelastine hydrochloride
(= 125 micrograms azelastine) and 50
micrograms fluticasone propionate.
Excipient with known effect:
This medicinal product contains benzalkonium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray, Suspension.
_Product imported from the UK:_
White homogeneous suspension
4 CLINICAL PARTICULARS
As per PA1332/045/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1332/045/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Disodium edetate
Glycerol
Microcrystalline cellulose
Carmellose sodium
Polysorbate 80
Benzalkonium chloride
Phenylethyl alcohol
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
In-use shelf life (after first use): 6 months
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not refrigerate or freeze.
6.5 NATURE AND CONTENTS